Associate Manufacturing Engineer

Burke Porter, an Ascential Technologies Brand; Ham Lake (MN); On-site; USD 75,000 - 90,000; Full time

Job summary

Burke Porter, an Ascential Technologies Brand, is seeking a manufacturing professional to design, implement, and optimize production processes in a cGMP environment. The role focuses on SOP/MBR development, data analysis, and process validation across equipment and computer systems.

You will lead risk assessments, drive continuous improvement with lean and Six Sigma methodologies, train staff, prepare change controls and CAPAs, and support commissioning, qualification, and validation activities

Qualifications

• Experience with cGMP manufacturing and validation projects.
• Ability to perform risk assessments and FMEA.
• Experience developing SOPs and MBRs.
• Strong troubleshooting and data analysis skills.

Responsibilities

• Assist in design, implementation, and optimization of manufacturing processing.
• Develop and maintain SOPs, MBRs, and work instructions.
• Monitor production data to identify trends and opportunities for improvement.
• Support validation projects for equipment and software, including commissioning and qualification.
• Assist in training production personnel on new equipment and processes.

Skills

Lean manufacturing

Six Sigma

FMEA

Troubleshooting

Job description

• Participates in and supports the design, implementation, and optimization of manufacturing processing including but not limited to:
• Develop and maintain Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions.
• Monitor and analyze production data to identify trends and opportunities for improvement.
• Improve efficiency, safety, and compliance, including existing and new processes.
• Participate in continuous improvement initiatives such as lean manufacturing and Six Sigma methodologies.
• Validation and implementation of manufacturing equipment and computer system/software validations.
• Conduct risk assessment on process steps and their ability to meet requirements.
• Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Identify and resolve technical issues impacting manufacturing performance.
• Provide technical support for troubleshooting equipment and process-related deviations.
• Assist in training production personnel on new equipment and processes.
• Ability to prepare/issue change controls, CAPAs, and investigations.
• Participates in and supports validation projects within the cGMP regulated manufacturing areas, including but not limited to:
• Prepare, review, and execute commissioning, qualification and validation documents for equipment and computerized systems/software.
• Supporting Project teams in: User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
• Ability to handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
• Assisting in troubleshooting of equipment/computer system issues, process characterization and root cause investigations.
• Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.
• Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.
  

• Participates in and supports the design, implementation, and optimization of manufacturing processing including but not limited to:
• Develop and maintain Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions.
• Monitor and analyze production data to identify trends and opportunities for improvement.
• Improve efficiency, safety, and compliance, including existing and new processes.
• Participate in continuous improvement initiatives such as lean manufacturing and Six Sigma methodologies.
• Validation and implementation of manufacturing equipment and computer system/software validations.
• Conduct risk assessment on process steps and their ability to meet requirements.
• Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Identify and resolve technical issues impacting manufacturing performance.
• Provide technical support for troubleshooting equipment and process-related deviations.
• Assist in training production personnel on new equipment and processes.
• Ability to prepare/issue change controls, CAPAs, and investigations.

• Participates in and supports validation projects within the cGMP regulated manufacturing areas, including but not limited to:
• Prepare, review, and execute commissioning, qualification and validation documents for equipment and computerized systems/software.
• Supporting Project teams in: User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
• Ability to handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
• Assisting in troubleshooting of equipment/computer system issues, process characterization and root cause investigations.
• Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.
• Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.
  

Salary range: $75,000 - $90,000 annually